CA2086515C - Stentless heart valve and holder - Google Patents
Stentless heart valve and holderInfo
- Publication number
- CA2086515C CA2086515C CA002086515A CA2086515A CA2086515C CA 2086515 C CA2086515 C CA 2086515C CA 002086515 A CA002086515 A CA 002086515A CA 2086515 A CA2086515 A CA 2086515A CA 2086515 C CA2086515 C CA 2086515C
- Authority
- CA
- Canada
- Prior art keywords
- aortic
- coronary
- valve
- combination
- millimeters
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Lifetime
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2427—Devices for manipulating or deploying heart valves during implantation
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S623/00—Prosthesis, i.e. artificial body members, parts thereof, or aids and accessories therefor
- Y10S623/90—Stent for heart valve
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- Health & Medical Sciences (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Prostheses (AREA)
Abstract
A stentless aortic heart valve(13) having a disposable holder(55) with removable handle(71) attached can be manually reversed by the physician during suturing to provide a relatively unobstructed view into the patient's aorta. A covering (32) applied to strategic regions on the exterior and interior of the device provides a firm ground for suturing the prosthetic heart valve into position, and for attaching the detachable holder.(55)
Description
2 ~
R~ck4~ou..~ of the T~vention Field of the ~rt The ~l ~ ~~nt invention i8 directed to ~ heart valve holder nnd more particular~y to ~ device for holding a ~tentless tissue heart valve prosthesis during implantation ~nd to ~ combination ~tentless t~ r~ he~rt valve prosthesis and detachable holder.
niScussion of ~he Prior ~rt Surgically-implanted heart valve ~LG~~heses have extenAe~ the life ex~e~ancy of many patients who had defective natural valves. Such prosthe~es can be either mechanical or derived from human or animal donors. The aortic prosthesis is implanted in the patient during a surgical procedure in which a 6egment of the aorta nearby the natural valve is ~lit open so that the malfunctioning leaflets can be cut out and the prosthetic valve is ~u~ed within an intact segment of the aorta adjacent to the heart. The eurgical ~1 G~edu~ e is exacting due to the Furgeon'~ cramped quarters. Holding the implant in place while the surgeon places the DuL~ es to attach it to the interior of the patient'~ aorta presents an especially difficult problem.
To aid the surgeon during the implant procedure, it is known to use both dicposable and nondisposable holders to position the valve during surgery. However, the known valve holders are large and cumbersome. For instance U.S.
Patent 3,409,013 describes a nondisposable ~urgical instrument having a shank with pivotal bowed jaWc mounted ~at one end for gripping a heart prosthesis having a ~u~le ~ing by the suture ring. Means is also provided for ~ & 8 ~ 5 ~ ~
_ holding taut a plurality of ~LUL__ to be ra~-e~ through the D~LuLe ring attached to the valve. The ~ L_ ~re meant to be used in 6ecuring the prosthetic valve into the patient'~ aorta. A ~ore recent development is the S dieposable valve holder disclosed in U.8. Patent 4,185,636, which al~o utilizes a plurality of circumferentially ~paced l-gs attached to central holder apparatu~. The ~ewing ring of the prosthetic heart valve i~ attached by ~L~L~ to a ~olding di~c ~lideably positioned upon the central rod of the valve holder. The~e known valve holders, howeve., are unwieldy and obstruct the 6urgeon'~ view. Moreover, thiC
type of valve holder requires that the prosthetic valve have a sewing ring for grasping by the holder or to which the holder is laboriously attached by DuLules immediately prior to the curgery.
Each of the known types of prosthetic heart valve also has its peculiar limitations. ~or instance, homografts from donor human heart~ are difficult to obtain in exact ~izes, cannot be sterilized, and require extensive tests to determine the risks of transmitting diseases and of donor tissue incompatibility. Merh~n~cal implants, although readily available in many types and ~izes, do not duplicate the natural means of attaching the leaflets to the aortic wall and are excessively rigid, thus making installation difficult.
Bioprostheses ~LGc~ed from animals provide an acceptable alternative to homografts and merhAnical valves becau~e they can be provided in acceptable quantities and in a variety of cizes, they are more flexible than mechanical models, and they can be sterilized and tested for ~ Ase. However animal valves are commonly trimmed by cutting away the aortic wall between the leaflets and leaving only the tissue to which leaflets are attached. To 2 ~
L the remaining structure, animal valves are u~ually ~upported by ~etallic or plastic ~tent~, often augmented by a ~ewing ring usually at~ach~A to the ~xterior of the prosthe~i6 to _id in surgical attachment ~nto the patient'~
aorta. The ~ewing ring and/or ~tent occupie~ ~pace in the patient's annulus, thereby r~ in~ the orifice area of the valve and ~ -~guently increa6ing ~uL~ulence and the ~~sure gradient. In addition, the ~tent tends to be somewhat rigid, requiring the leaflet~ to ab~orb much of the ~tress during valve closure. Becau~e the heart beats a~oximately 40 ~illion time~ per ye r with closing pressures up to 4 psi, ~ignificant fatigue and wear can occur to a heart ~alve leaflet when it must absorb the ~tress caused by heartbeat.
It is common practice to tan animal valves to render the animal ti~sue relatively inert with respect to the living host environment and to provide a fixed configuration. As disclosed in ~Ancock et al U.S. Patents 3,966,401 and 4,050,893 and Angell et al U.S. Patent 3,983,581, animal heart valves can be tanned using a nning fluid under differential pressures across the valve ranging from 20 mm Hg to 120 mm Hg. However, it i~ known that obtaining fixation at these high internal pressures results in considerable loss of resilience to the collagen fibers in the heart valve. As disclosed in Lane U.S.
Patent 4,372,743, a preferred method of fixation at low pressure elim~nate~ these difficulties. According to this low pressure method, fixation of an animal heart valve is accomplished without substantial lo~s in resilience to the internal collagen fibers and without shrinkage of the valve by ~ubjecting it to a t~nning fluid, preferably glutaraldehyde, at a differential pressure across the valve of from zero to 4 mm Hg. In this prore~lre, an internal mechAnical restraint is positioned within the valve prior 4 2û865 ~ 5 to fixation so as to prevent shrinkage and distortion of the valve during the fixation step. the internal restraint is removed once the valve ha~ been tanned.
Despite the advantages provided by low pressure tanning, it can be seen from the foregoing discussion that the need exists for new and improved aortic heart valves, especially those derived from animal donors, and for holder~ that aid in their surgical implant.
SUMMARY OF THE INVENTION
Various aspect of the invention are as follows:
A stentless aortic valve prosthesis comprising an animal aortic segment having an external surface and an internal surface, the aortic segment further comprising an aortic root, an outflow rim adjacent the aortic root, an inflow rim, a left coronary artery, a right coronary artery, a right coronary septal shelf, a plurality of valve leaflets, each va~ve leaflet having cusps and edges with the adjacent edges of the valve leaflets meeting to form commissures, a pse~o~nnulus line located adjacent the commissures along the internal surface of the aortic segment, and coronary openings formed by cutting away the left and right coronary arteries while leaving intact a band of aortic wall adjacent the outflow rim.
A stentless aortic valve prosthesis comprising an ~n;~l aortic segment having an external surface and an internal surface, the aortic segment further comprising an aortic root, an outflow rim adjacent the aortic root, an inflow rim, a left coronary artery, a right coronary artery, a right coronary septal shelf, a plurality of valve leaflets, each valve leaflet having cusps and edges with the B
~ ~ .
~ o ~ ~ 5 ~ 5 4a adjacent edges of the valve leaflets meeting to form commissures, and a pseudoannulus line located adjacent the commissures along the internal surface of the aortic segment, the aortic segment further comprlslng:
coronary openings formed by cutting away the left and right coronary arteries while leaving intact a band of aortic wall adjacent the outflow rim; and a suturable covering affixed along the entire right coronary septal shelf on the external surface of the aortic segment, and the inflow rim on both the internal and external surfaces of the aortic segment;
the suturable covering comprising edges and covering, at the outflow rim, an area r~nn;ng along the internal surface of the aortic segment between the pseudoannulus line and the coronary openings, leaving uncovered a portion of aortic wall between the edges of the suturable covering and each commissure.
A combination valve holder and prosthetic aortic segment comprising:
a stentless aortic valve prosthesis comprising an animal aortic segment having an external surface and an internal surface, the aortic segment further comprising an aortic root, an outflow rim adjacent the aortic root, an inflow rim, a left coronary artery, a right coronary artery, a right coronary septal shelf, a plurality of valve leaflets, each valve leaflet having cusps and edges with the adjacent edges of the valve leaflets meeting to form commissures, a pseudoannulus line located adjacent the commissures along the internal surface of the aortic segment, and coronary openings formed by cutting away the left and right coronary arteries while leaving intact a band of aortic wall adjacent the outflow rim;
a disposable holder body having an elongate detachable handle; and B
~ Q ~
4b a plurality of means for detachably attaching the holder body to the covering on the aortic segment.
By way of added explanation, many of the above-described problems are overcome by the stentless animal aortic valve prosthesis disclosed herein. The invention provides a reversible stentless animal heart valve, preferably porcine, tanned at low pressure to retain natural flexibility. Instead of a stent or sewing ring the prosthesis has a minimal biocompatible suturable covering, preferably cloth, along the inflow rim of the valve to reinforce the suture attachment of the artificial valve to the human heart valve annulus. Thus a minimum of critical space in the annulus is taken up by the prosthetic device and the amount of turbulence in the annulus caused by the prosthesis is thereby decreased.
The aortic segment is left untrimmed except for removal of the right and left coronary arteries so that an intact band of aorta remains above the two coronary openings for the purpose of maintaining commissural alignment and preventing valvular distortion during implantation. However, the portions of aortic segment contiguous to the coronary openings optionally can be trimmed away by the surgeon without impairing the shape or function of the valve.
B
2~8~5~
_ A ~i-po--hle valve holder body i~ al~o provided, being a tiny pla~tic member for preattachment to the valve at the time of manufacture. The stentle6~ valve and valve holder thu~ can be etored and ~old as a ~ingle unit.
s To prepare the animal valve for tanning~ a ~egment of animal aorta having attarb~A ~tubs of the left and right coronary artery i~ eYcir~~ from an animal heart, prefer_bly porcine, making ~ure that an intact band of aorta remain~
thereabove and that the three valve leaflet~ and the ~inl~FE- of Val~alva al~o remain intact.
Preferably only those valves are ~elected for use that have a uniform lateral profile. To ~levent distortion _ functions like a sewing ring in providing the physician with a firm ~.o~.~ for suturing the prosthesis into place.
m e covering extends along the ~nflow rim, both internally and ~xternally, and along the exterior surface of the entire right coronary ~eptal ~helf. To provide the ~ eo~l with a guide to suture placement, the covering can be ~ewn along the ~nflow ~nn~lus with ~uture of a ~G--L~a~ting color. ~ar~n~ of any type clearly vi~ible to the surgeon during implant and located on the surface of the covering along the inflow rim above the center of each of the three valve cusps aid the ~urgeon in aligning the valve within the patient'~ natural aorta. Thus the ~urgeon can place the implant ~o as to closely mimic the orientation of the damaged natural valve despite his limited field of vision within the patient'~ natural aorta.
On the outflow side of the valve, pieces of covering are placed internally as a D~Ol ~ for the ~econ~ ~Lu,e line.
Because the animal heart valve of this invention is not encumbered by a rigid stent, it can optionally be trimmed by the physician at any time during the implant surgery to remove portions of the band of aortic material along the inflow side of the valve. This advantage allows the surgeon to tailor the prosthe6is to meet the individual needs of the patient. In addition, due to its flexibility, the unstented valve can be inverted by the surgeon during implantation, thu~ providing a clearer field of vision to the ~ eG~ during implantation.
The di~r~hle stentles6 valve holder is preferably sized for insertion into the aortic opening of the stentless heart valve without obstructing the area of the first suture line or the view down into the valve. It is fashioned of any biocompatible material, preferably g ~
_ moldable al~ho~gh ~achin-ble ~aterial6 ~re acreptable, including, for example, polyoer, ceramic and ~etallic materials. ~nd comprises a holder body with means for detachably affixing the holder body to the ~tentless aortic S valve prosthesi~, ~06t preferably auspending it within the outflow ~ide of the orifice. ~eans for ~ecuring the holder body to the heart valve i~ provided a6 well ~ a detachable h~n~le, preferably ~ threaded elongate rod of biocompatible metal, ceramic, or plastic that ~crews into a cylindrical, threaded depre6sion ln the holder body.
Preferably the holder body ig ~180 cylindrical and h~s a circumferential rim with a plurality of small ~p~ings through which DU~ 2 lines or other means of attachment, for example wires or elastic ~aterials, and the like, can be pAS~ to detachably affix or ~u~pend the holder body within the inflow orifice of the prosthetic valve. The holder body is designed to be attached to the stentless valve at the time of manufacture 80 that the stentless valve and diD~ hle holder can be packaged, stored, and purch~e~ as a unit.
After manufacture the combination heart valve and holder are usually stored submerged in a ~olution of glutaraldehyde or other ~ ervative in a closed cont~iner.
In such a case, the holder is made of a material relatively inert to the storage fluid.
As mentioned above, if the holder body is su~penAeA
within the outflow orifice, the stentless valve can optionally be ~anually inverted by the surgeon. The detachable h~nAle should usually be attached to the holder after the valve is inverted to avoid damage to the valve when it is being inverted. Then, holding the valve by the detachable handle, the ~urgeon or an assistant can rotate thë valve within the patient's natural aorta to position it - 8 2~
and keep it ~ arly aligned while the fir~t ~uture line is placed to secure the implant. If inverted, the ~alve can be guickly ~ev~l~ed to its natural configuration before the ~econA ~U~l. line i~ placed.
Whether or not the ~lve i~ initially inverted, the holder and detachable h-n~le of thi~ invention provide the ~urgeon and his ~urgical te~m with a relatively unob6tructed view while the fir~t ~ù~u e line is ~ade. The h-n~le of the holder can be removed by detaching it (i.e., unecrewing it) at any time during the impl_nt ~ G~ e l~ e.
Once the prosthe~is has been ~ hed into place, the holder body can al~o be removed by detaching the means of attachment ~ecuring the holder body to the valve. For instance, if the holder body is suspended within the outflow orifice by ~u~e lines, these c_n be snipped, and the holder body withdrawn.
BRIEF DESCRIPTION OF THE DRAWINGS
FIGURE 1 is a view of the aortic 6egment before trimming.
FIGURE 2 ie ~ view of the aortic segment with cylindrical ~u~o~s inserted into the leaflets preparatory to t~ g.
FIGURE 3 is a view of the stentless aortic valve from the in-flow 6ide showing the Du~u~&ble cloth covering along the inflow rim and the ~urface of the right coronary ~eptal ~helf.
FIGURE 4 is a view of the ~tentless aortic valve from the out-flow side showing the ~ able cloth co~ering along the pseudoannulus _nd coronary artery openings.
FIGURE 5 is a top view of the holder body.
~f g ~ U ~
_ FIGURE 6 i~ a ~ide view of the holder body and detachable h~n~le.
FIGURE 7 is a perepective view of the ~tentless aortic valve showing the ~older ~ody with handle att~
S ~uspended within the inflow orifice of the valve.
A D~ ON OF THE ~r~KK~v EMBODIMENTS
The ~tentle~ heart valve herein is prepared by securing a portion of an animal aortic root, preferably porcine, including the intact aortic valve. As 6hown in Figure 1, the etumps of the left and right coronary arteries 3 and 5, respectively, are tied off and only minimal trimming to remove ~ess fat and loo~e ti~sue is done to prevent distortion of aortic root 9 during fixation. The valve is preferably tanned according to the low pressure method described in U.S. Patent 4,372,743, which is incorporated herein by reference in its entirety.
The t~nning ~olution i8 preferably glutaraldehyde, most preferably a buffered eolution ~uch as 0.625% Hepes buffered glutaraldehyde.
Although low pressure tAn~ing can be conducted at pressures up to 20 mm Hg, it has been found that maximum flexibility is retained when the pressure i6 maintained below about 10 mm Hg, most preferably about 2 mm Hg. As shown in Figure 2, cylindrical inserts 2 are inserted into the leaflets of the aortic ~egment 4 during the tAnning process to maintain the natural unstressed 6hape of the valve.
After tAnning~ the valve i~ 6terilized by 6ubmerging it in a biocompatible ~terilizing 601ution, preferably one that helps to reduce calcification. For instance an agueous ~olution buffered with ~epes and containing 4.0 percent formaldehyde, 22 percent ethanol, 1.2 percent Tween ~- 10 - 80 (FETH), or a ~imilar ~olution buffered with phocphate (FETS) can be u6ed. Then the prosthetic valve is sized using caliper6 to determine its out~ide diameter, ~ Ally ro~nd~ off to the nearest ~illimeter. For commercial application6, a valve whose out~ide diameter does not ~o~.d off to an odd number ~etween 15 ~nd 27, inclu6ively, is ~-r--~lly re~ected.
After ~izing the valve6 are ~ub~ected to a ~econd trimming ~tep ~n which cub~tantially all of the myocardial tissue i8 shaved away, leaving a thin cartilage rim adjacent to the right coronary septal ~helf for reinforcement. The left and right coronary arteries are cut out following the ~-c~ ann~lAr line but leaving eno~gh tissue to protect the commi6sures. Preferably the cut is made 80 that about 2 to 4 mm of t~-F'l~ remains from the edge of the hole to the pseudo-~nn~lA~ line, and about 3 to 5 mm of tis~ue remain~ between the hole edge and the commissures. All trimming i6 conducted with the goal of leaving an intact band of aorta about 2 to 5 mm in width above the two coronary oren;nqs 47. The intact band of aorta is necess~ry to maintain proper alignment of the commissures and prevent distortion of the valves during suturing.
Finally, the inflow rim is trimmed on the ~ame plane as the cusps of the leaflets, usually leaving an intact segment of about 3 to 4 mm in width a~ measured from the hinge of the leaflet. All of the fatty tissue in the aorta i~ trimmed away.
As 6hown in Figure 3, the resulting aortic ~egment contains three valve leaflet~, each of which is affixed to the aortic ~egment at a ~uncture. Aortic valve 13, excised from a porcine heart, includes a tubular aortic 6egment of the ascending aorta 19 and three valve leaflets 21, 23, and ; ll 2~3~5~
_ 25. The bulk of the ~yocardial t~ ? has been trimmed from valve 13 to ~inimize distortion during $ixation, and the coron~ry arteries (not shown) have been cut out as above described. Adjacent ~dge~ of the valve leaflets 21,23, and 25 ~eet to form eommi~sures 27 at the ~unctions between adjacent valve leaflets. Each of the valve leaflet~ 21, 23 and 25 can be con~idered a~ ~oined to ~rcenAing aorta 19 along a ~uncture 29. The wall of the ~cenA;ng aorta 19 adjacent ~ ~u~e 29 form~ ~n"re~ of Valsalva (not ~hown). Valve leaflet 21, the right coronary leaflet, iB positioned ~omewhat asymmetrically with ~ ect to the other two leaflets.
The cloth covering i8 made of any ~mooth, thin biocompatible material D L. ~ly ~no--7h to hold sutures, but is preferably of white dacron, ~uch as that manufactured by Bard Cardiosurgery Division, C. R. Bard, Inc. under part no. 6103, having a thic~ne~s of .008 ~c~es and a weight of 72 grams per ~quare meter. The cloth is cut on the diagonal to assure a snug fit around ~Lved surfaces, cleaned to remove contaminants such as dirt and lint, preferably by submerging in Freon for 60 ~econ~, and sterilized.
As shown in Figure 3, at the inflow end the entire right coronary septal shelf 33 is covered externally by a piece of cloth 32 stitched into place, preferably by hand, using a nondi~solvable biocompatible thread and whipstitches 35 at the thin rim adjacent to the right coronary septal ~helf 37. The inflow rim 39 is covered, preferably starting at the ~u..e~u-e of the left and noncoronary cusps 41, by a piece of cloth 32 folded at the half-width ~o that approximately 2.S mm. of cloth extends on each side of the fold. The rim to be covered is placed within the fold. Therefore, the cloth covering extends SJ1~
~long the inflow rim, both internally and externally, and along the exterior curface of the entire right coronary ~eptal ~helf. Preferably this ~egment of cloth i~ a ~ingle piece.
s ~ arking~ 43, for example, ~titches ~n a ~G..L.~sting color of thread, are located on the cloth curface along the inflow rim, preferably at the ~id-cusp point of each leaflet, to ~id the ~u~eG~ in ~ligning the valve within the patient's natural aorta. For in~tance, if the cloth is white, the marking can be ctitches of navy blue threAd, ~nd the like. An exemplary light green marking thread is Polyester Teflon Coated Polydek, ~ize 6.0, having a denier of 110-130 manufa~L~ed by Dekatel C~o~ation, Queens Village, New York.
As ~hown in Figure 4, at the outflow ~ide, cloth 32 is sewn only on the internal portion of the valve. Surgeons use the coverings on the outflow ~ide of the valve as an anchor and a ~Lule guide, ~o they must be placed far enough from the leaflets to pose no risk of placing a suture through the leaflet and thus damaging or rendering the valve incompetent. Two pieces of cloth are required, cut diagonally by laser to about 2 to 4 mm, preferably about 2.5 to 3.5 mm in width, to run along and match the shape of edge of the coronary artery openings. The length of these pieceC of cloth is determined by the reguirement that about 1 to 4 mm, prefer~bly about 2.5 to 3.0 mm of ~pace, must be left between each end of the cloth and the nearest commi~ure 48.
As ~hown in detail in Figure 4, at outflow rim 46 cloth 32 i~ sewn to cover the area running internally directly along the pseudoannulus 45 of the valve and over the cutouts for both the right and left coronary arteries ~3 47, but the ~L~ e cribed ~-~o~ered np~le is left L~/aen the edges of the cloth and each valve commi6sure.
The cloth covering thu~ giveQ ~u~v~L to an area commonly known in the art a~ the -~con~ .~L~e line and provide~
secure ~un~ for the ~u~eo.. to place the ~econd line.
The cloth piece~ are permanently attached to the aortic ~egment by stitch~g them into place w~th fine ~titches, preferably by hand, u~ing ~ ~n~ olvable biocompatible thread. Preferably one edge of the cloth is cecured by a line of in-and-out ~titches 51 about 0.5 mm in length placed immediately above the ~ s~nnulus line utilizing Teflon thread ~uch as that manufa~L~ed by W. L.
Gore and ~crocjAteC~ Inc., Elkton, MD., having a denier of 200-250, monofilament zero twi t (Part ~ YlD162 PTFE). The other edge of the cloth i8 ~u~led to the hole edge with whipstitches 53 ~n~ng along the inside of the coronary open;n~s using the ~ame piece of Teflon thread, while making sure that the cloth is fluuh with the hole edge.
Although the valve holder body can be of any cize and shape ~uitable to be ~ecured adjacent to the aortic 6egment and made of a biocompatible substance, valve holder body 55 preferably comprises two cylindrical ~egments extruded from a biocompatible plastic ~uch as transparent polysulfone thermoplastic ~old by Union Carbide Co~oL&tion as part P 1700-11, having a tensile yield ~trength of 9,500 psi min. Preferably the holder body is ~ized to fit within the ~en;~g of the aortic ~egment.
As ~hown in Figures 5 and 6, a first cylindrical ~egment 57 of valve holder body 55 has axis 59 and is hollow, having an internal diameter of from about 3.5 mm to 6.5 mm, and an external diameter of from about 5 mm to 10 ~ . ~ ~
14 2~ 51~
- mm, ~ost preferably about 7 Ym, and a length of from about 4 mm to 16 mm, Dost preferably about 6 ~m. Joined thereto and ~oaY~ al ly aligned therewith i6 -eCOnA
eylindrieal ~egment 61 having an external diameter of from S about 8 D to 13 ~m, ~o~t preferably ~bout lO mm, and length of from about 2 D to 8 D, ~ost preferably ~bout 4 mm. A ~oaYially aligned eylindrieal d~ ion 63 extends into eylindrieal ~egment 61 for a depth egual to about one half the length of the ~egment. The diameter of eylindrieal ~ ion C3 i~ egual to the internal diameter of fir~t eylindrieal ~egment 57. Therefore, with fir~t and Aecon~ eylindrieal ~egments ~oined, the interior wall of eylindrieal 6egment 57 and eylindrieal depression 63 define eylindrieal ~pace 65, the ~ides of whieh have threads (not ~hown) for receiving the threaded end 69 of ~n~le 71.
uAn~le 71 i~ a eylindrieal rod ~ized to fit into eylindrieal spaee 65 by means of threads at end 69 ~o that handle 71 ean be ~lewe-l into valve holder body 55. Holes 80 extend through eylindrieal ~egment 61 to provide a means for attaching the holder body to the prosthetie aortic valve.
Any of a number of Deans ean be used for detachably eonnecting the holder body to the heart valve so long as they do not eompromise the integrity of the leaflets. The preferred means for attaching the holder body to an aortic prosthesis i~ ~hown in Figure 7. From one to about six, most preferably four, loose ~uture threads 81 are threaded through holes 80 provided in the holder body as well as eompletely through the wall of the outflow ~ide of the aortie segment 55, preferably through the tissue above the openings for the eoronary arteries 47. The ~uture threads are then fastened (i.e. tied) as shown in Figure 7 ~o that the holder body hangs ~uspended within the 6aid outflow opening. This ~imple Deans of attaehment ean readily be 2 ~ ~ ~ J .~ ~
snipped by the surgeon and the holder body and BULULe~ can be removed once the first suture line h~s been placed, or at ~ny time during the surgical implant ~ re.
As an ~dditional advantage, the band of aortic segment on the outflow ~ide of the valve optionally can be trimmed to fit the needs of the part~ r patient and/or the likings of the surgeon. For instance the outflow ~ide of the valve can be trimmed ~o as to completely remove the portion of the aortic band ~xt~n~ ng between the outflow rim and the coronary artery openings. Trimming the flexible prosthetic valve in this way does not de_L~oy its natural shape or function.
Although exemplary embodiments of the invention have been shown and described, many changes, modifications and substitutions may be made by one having ordinary skill in the art without nec~6s~rily departing from the spirit and scope of the invention described and claimed herein.
R~ck4~ou..~ of the T~vention Field of the ~rt The ~l ~ ~~nt invention i8 directed to ~ heart valve holder nnd more particular~y to ~ device for holding a ~tentless tissue heart valve prosthesis during implantation ~nd to ~ combination ~tentless t~ r~ he~rt valve prosthesis and detachable holder.
niScussion of ~he Prior ~rt Surgically-implanted heart valve ~LG~~heses have extenAe~ the life ex~e~ancy of many patients who had defective natural valves. Such prosthe~es can be either mechanical or derived from human or animal donors. The aortic prosthesis is implanted in the patient during a surgical procedure in which a 6egment of the aorta nearby the natural valve is ~lit open so that the malfunctioning leaflets can be cut out and the prosthetic valve is ~u~ed within an intact segment of the aorta adjacent to the heart. The eurgical ~1 G~edu~ e is exacting due to the Furgeon'~ cramped quarters. Holding the implant in place while the surgeon places the DuL~ es to attach it to the interior of the patient'~ aorta presents an especially difficult problem.
To aid the surgeon during the implant procedure, it is known to use both dicposable and nondisposable holders to position the valve during surgery. However, the known valve holders are large and cumbersome. For instance U.S.
Patent 3,409,013 describes a nondisposable ~urgical instrument having a shank with pivotal bowed jaWc mounted ~at one end for gripping a heart prosthesis having a ~u~le ~ing by the suture ring. Means is also provided for ~ & 8 ~ 5 ~ ~
_ holding taut a plurality of ~LUL__ to be ra~-e~ through the D~LuLe ring attached to the valve. The ~ L_ ~re meant to be used in 6ecuring the prosthetic valve into the patient'~ aorta. A ~ore recent development is the S dieposable valve holder disclosed in U.8. Patent 4,185,636, which al~o utilizes a plurality of circumferentially ~paced l-gs attached to central holder apparatu~. The ~ewing ring of the prosthetic heart valve i~ attached by ~L~L~ to a ~olding di~c ~lideably positioned upon the central rod of the valve holder. The~e known valve holders, howeve., are unwieldy and obstruct the 6urgeon'~ view. Moreover, thiC
type of valve holder requires that the prosthetic valve have a sewing ring for grasping by the holder or to which the holder is laboriously attached by DuLules immediately prior to the curgery.
Each of the known types of prosthetic heart valve also has its peculiar limitations. ~or instance, homografts from donor human heart~ are difficult to obtain in exact ~izes, cannot be sterilized, and require extensive tests to determine the risks of transmitting diseases and of donor tissue incompatibility. Merh~n~cal implants, although readily available in many types and ~izes, do not duplicate the natural means of attaching the leaflets to the aortic wall and are excessively rigid, thus making installation difficult.
Bioprostheses ~LGc~ed from animals provide an acceptable alternative to homografts and merhAnical valves becau~e they can be provided in acceptable quantities and in a variety of cizes, they are more flexible than mechanical models, and they can be sterilized and tested for ~ Ase. However animal valves are commonly trimmed by cutting away the aortic wall between the leaflets and leaving only the tissue to which leaflets are attached. To 2 ~
L the remaining structure, animal valves are u~ually ~upported by ~etallic or plastic ~tent~, often augmented by a ~ewing ring usually at~ach~A to the ~xterior of the prosthe~i6 to _id in surgical attachment ~nto the patient'~
aorta. The ~ewing ring and/or ~tent occupie~ ~pace in the patient's annulus, thereby r~ in~ the orifice area of the valve and ~ -~guently increa6ing ~uL~ulence and the ~~sure gradient. In addition, the ~tent tends to be somewhat rigid, requiring the leaflet~ to ab~orb much of the ~tress during valve closure. Becau~e the heart beats a~oximately 40 ~illion time~ per ye r with closing pressures up to 4 psi, ~ignificant fatigue and wear can occur to a heart ~alve leaflet when it must absorb the ~tress caused by heartbeat.
It is common practice to tan animal valves to render the animal ti~sue relatively inert with respect to the living host environment and to provide a fixed configuration. As disclosed in ~Ancock et al U.S. Patents 3,966,401 and 4,050,893 and Angell et al U.S. Patent 3,983,581, animal heart valves can be tanned using a nning fluid under differential pressures across the valve ranging from 20 mm Hg to 120 mm Hg. However, it i~ known that obtaining fixation at these high internal pressures results in considerable loss of resilience to the collagen fibers in the heart valve. As disclosed in Lane U.S.
Patent 4,372,743, a preferred method of fixation at low pressure elim~nate~ these difficulties. According to this low pressure method, fixation of an animal heart valve is accomplished without substantial lo~s in resilience to the internal collagen fibers and without shrinkage of the valve by ~ubjecting it to a t~nning fluid, preferably glutaraldehyde, at a differential pressure across the valve of from zero to 4 mm Hg. In this prore~lre, an internal mechAnical restraint is positioned within the valve prior 4 2û865 ~ 5 to fixation so as to prevent shrinkage and distortion of the valve during the fixation step. the internal restraint is removed once the valve ha~ been tanned.
Despite the advantages provided by low pressure tanning, it can be seen from the foregoing discussion that the need exists for new and improved aortic heart valves, especially those derived from animal donors, and for holder~ that aid in their surgical implant.
SUMMARY OF THE INVENTION
Various aspect of the invention are as follows:
A stentless aortic valve prosthesis comprising an animal aortic segment having an external surface and an internal surface, the aortic segment further comprising an aortic root, an outflow rim adjacent the aortic root, an inflow rim, a left coronary artery, a right coronary artery, a right coronary septal shelf, a plurality of valve leaflets, each va~ve leaflet having cusps and edges with the adjacent edges of the valve leaflets meeting to form commissures, a pse~o~nnulus line located adjacent the commissures along the internal surface of the aortic segment, and coronary openings formed by cutting away the left and right coronary arteries while leaving intact a band of aortic wall adjacent the outflow rim.
A stentless aortic valve prosthesis comprising an ~n;~l aortic segment having an external surface and an internal surface, the aortic segment further comprising an aortic root, an outflow rim adjacent the aortic root, an inflow rim, a left coronary artery, a right coronary artery, a right coronary septal shelf, a plurality of valve leaflets, each valve leaflet having cusps and edges with the B
~ ~ .
~ o ~ ~ 5 ~ 5 4a adjacent edges of the valve leaflets meeting to form commissures, and a pseudoannulus line located adjacent the commissures along the internal surface of the aortic segment, the aortic segment further comprlslng:
coronary openings formed by cutting away the left and right coronary arteries while leaving intact a band of aortic wall adjacent the outflow rim; and a suturable covering affixed along the entire right coronary septal shelf on the external surface of the aortic segment, and the inflow rim on both the internal and external surfaces of the aortic segment;
the suturable covering comprising edges and covering, at the outflow rim, an area r~nn;ng along the internal surface of the aortic segment between the pseudoannulus line and the coronary openings, leaving uncovered a portion of aortic wall between the edges of the suturable covering and each commissure.
A combination valve holder and prosthetic aortic segment comprising:
a stentless aortic valve prosthesis comprising an animal aortic segment having an external surface and an internal surface, the aortic segment further comprising an aortic root, an outflow rim adjacent the aortic root, an inflow rim, a left coronary artery, a right coronary artery, a right coronary septal shelf, a plurality of valve leaflets, each valve leaflet having cusps and edges with the adjacent edges of the valve leaflets meeting to form commissures, a pseudoannulus line located adjacent the commissures along the internal surface of the aortic segment, and coronary openings formed by cutting away the left and right coronary arteries while leaving intact a band of aortic wall adjacent the outflow rim;
a disposable holder body having an elongate detachable handle; and B
~ Q ~
4b a plurality of means for detachably attaching the holder body to the covering on the aortic segment.
By way of added explanation, many of the above-described problems are overcome by the stentless animal aortic valve prosthesis disclosed herein. The invention provides a reversible stentless animal heart valve, preferably porcine, tanned at low pressure to retain natural flexibility. Instead of a stent or sewing ring the prosthesis has a minimal biocompatible suturable covering, preferably cloth, along the inflow rim of the valve to reinforce the suture attachment of the artificial valve to the human heart valve annulus. Thus a minimum of critical space in the annulus is taken up by the prosthetic device and the amount of turbulence in the annulus caused by the prosthesis is thereby decreased.
The aortic segment is left untrimmed except for removal of the right and left coronary arteries so that an intact band of aorta remains above the two coronary openings for the purpose of maintaining commissural alignment and preventing valvular distortion during implantation. However, the portions of aortic segment contiguous to the coronary openings optionally can be trimmed away by the surgeon without impairing the shape or function of the valve.
B
2~8~5~
_ A ~i-po--hle valve holder body i~ al~o provided, being a tiny pla~tic member for preattachment to the valve at the time of manufacture. The stentle6~ valve and valve holder thu~ can be etored and ~old as a ~ingle unit.
s To prepare the animal valve for tanning~ a ~egment of animal aorta having attarb~A ~tubs of the left and right coronary artery i~ eYcir~~ from an animal heart, prefer_bly porcine, making ~ure that an intact band of aorta remain~
thereabove and that the three valve leaflet~ and the ~inl~FE- of Val~alva al~o remain intact.
Preferably only those valves are ~elected for use that have a uniform lateral profile. To ~levent distortion _ functions like a sewing ring in providing the physician with a firm ~.o~.~ for suturing the prosthesis into place.
m e covering extends along the ~nflow rim, both internally and ~xternally, and along the exterior surface of the entire right coronary ~eptal ~helf. To provide the ~ eo~l with a guide to suture placement, the covering can be ~ewn along the ~nflow ~nn~lus with ~uture of a ~G--L~a~ting color. ~ar~n~ of any type clearly vi~ible to the surgeon during implant and located on the surface of the covering along the inflow rim above the center of each of the three valve cusps aid the ~urgeon in aligning the valve within the patient'~ natural aorta. Thus the ~urgeon can place the implant ~o as to closely mimic the orientation of the damaged natural valve despite his limited field of vision within the patient'~ natural aorta.
On the outflow side of the valve, pieces of covering are placed internally as a D~Ol ~ for the ~econ~ ~Lu,e line.
Because the animal heart valve of this invention is not encumbered by a rigid stent, it can optionally be trimmed by the physician at any time during the implant surgery to remove portions of the band of aortic material along the inflow side of the valve. This advantage allows the surgeon to tailor the prosthe6is to meet the individual needs of the patient. In addition, due to its flexibility, the unstented valve can be inverted by the surgeon during implantation, thu~ providing a clearer field of vision to the ~ eG~ during implantation.
The di~r~hle stentles6 valve holder is preferably sized for insertion into the aortic opening of the stentless heart valve without obstructing the area of the first suture line or the view down into the valve. It is fashioned of any biocompatible material, preferably g ~
_ moldable al~ho~gh ~achin-ble ~aterial6 ~re acreptable, including, for example, polyoer, ceramic and ~etallic materials. ~nd comprises a holder body with means for detachably affixing the holder body to the ~tentless aortic S valve prosthesi~, ~06t preferably auspending it within the outflow ~ide of the orifice. ~eans for ~ecuring the holder body to the heart valve i~ provided a6 well ~ a detachable h~n~le, preferably ~ threaded elongate rod of biocompatible metal, ceramic, or plastic that ~crews into a cylindrical, threaded depre6sion ln the holder body.
Preferably the holder body ig ~180 cylindrical and h~s a circumferential rim with a plurality of small ~p~ings through which DU~ 2 lines or other means of attachment, for example wires or elastic ~aterials, and the like, can be pAS~ to detachably affix or ~u~pend the holder body within the inflow orifice of the prosthetic valve. The holder body is designed to be attached to the stentless valve at the time of manufacture 80 that the stentless valve and diD~ hle holder can be packaged, stored, and purch~e~ as a unit.
After manufacture the combination heart valve and holder are usually stored submerged in a ~olution of glutaraldehyde or other ~ ervative in a closed cont~iner.
In such a case, the holder is made of a material relatively inert to the storage fluid.
As mentioned above, if the holder body is su~penAeA
within the outflow orifice, the stentless valve can optionally be ~anually inverted by the surgeon. The detachable h~nAle should usually be attached to the holder after the valve is inverted to avoid damage to the valve when it is being inverted. Then, holding the valve by the detachable handle, the ~urgeon or an assistant can rotate thë valve within the patient's natural aorta to position it - 8 2~
and keep it ~ arly aligned while the fir~t ~uture line is placed to secure the implant. If inverted, the ~alve can be guickly ~ev~l~ed to its natural configuration before the ~econA ~U~l. line i~ placed.
Whether or not the ~lve i~ initially inverted, the holder and detachable h-n~le of thi~ invention provide the ~urgeon and his ~urgical te~m with a relatively unob6tructed view while the fir~t ~ù~u e line is ~ade. The h-n~le of the holder can be removed by detaching it (i.e., unecrewing it) at any time during the impl_nt ~ G~ e l~ e.
Once the prosthe~is has been ~ hed into place, the holder body can al~o be removed by detaching the means of attachment ~ecuring the holder body to the valve. For instance, if the holder body is suspended within the outflow orifice by ~u~e lines, these c_n be snipped, and the holder body withdrawn.
BRIEF DESCRIPTION OF THE DRAWINGS
FIGURE 1 is a view of the aortic 6egment before trimming.
FIGURE 2 ie ~ view of the aortic segment with cylindrical ~u~o~s inserted into the leaflets preparatory to t~ g.
FIGURE 3 is a view of the stentless aortic valve from the in-flow 6ide showing the Du~u~&ble cloth covering along the inflow rim and the ~urface of the right coronary ~eptal ~helf.
FIGURE 4 is a view of the ~tentless aortic valve from the out-flow side showing the ~ able cloth co~ering along the pseudoannulus _nd coronary artery openings.
FIGURE 5 is a top view of the holder body.
~f g ~ U ~
_ FIGURE 6 i~ a ~ide view of the holder body and detachable h~n~le.
FIGURE 7 is a perepective view of the ~tentless aortic valve showing the ~older ~ody with handle att~
S ~uspended within the inflow orifice of the valve.
A D~ ON OF THE ~r~KK~v EMBODIMENTS
The ~tentle~ heart valve herein is prepared by securing a portion of an animal aortic root, preferably porcine, including the intact aortic valve. As 6hown in Figure 1, the etumps of the left and right coronary arteries 3 and 5, respectively, are tied off and only minimal trimming to remove ~ess fat and loo~e ti~sue is done to prevent distortion of aortic root 9 during fixation. The valve is preferably tanned according to the low pressure method described in U.S. Patent 4,372,743, which is incorporated herein by reference in its entirety.
The t~nning ~olution i8 preferably glutaraldehyde, most preferably a buffered eolution ~uch as 0.625% Hepes buffered glutaraldehyde.
Although low pressure tAn~ing can be conducted at pressures up to 20 mm Hg, it has been found that maximum flexibility is retained when the pressure i6 maintained below about 10 mm Hg, most preferably about 2 mm Hg. As shown in Figure 2, cylindrical inserts 2 are inserted into the leaflets of the aortic ~egment 4 during the tAnning process to maintain the natural unstressed 6hape of the valve.
After tAnning~ the valve i~ 6terilized by 6ubmerging it in a biocompatible ~terilizing 601ution, preferably one that helps to reduce calcification. For instance an agueous ~olution buffered with ~epes and containing 4.0 percent formaldehyde, 22 percent ethanol, 1.2 percent Tween ~- 10 - 80 (FETH), or a ~imilar ~olution buffered with phocphate (FETS) can be u6ed. Then the prosthetic valve is sized using caliper6 to determine its out~ide diameter, ~ Ally ro~nd~ off to the nearest ~illimeter. For commercial application6, a valve whose out~ide diameter does not ~o~.d off to an odd number ~etween 15 ~nd 27, inclu6ively, is ~-r--~lly re~ected.
After ~izing the valve6 are ~ub~ected to a ~econd trimming ~tep ~n which cub~tantially all of the myocardial tissue i8 shaved away, leaving a thin cartilage rim adjacent to the right coronary septal ~helf for reinforcement. The left and right coronary arteries are cut out following the ~-c~ ann~lAr line but leaving eno~gh tissue to protect the commi6sures. Preferably the cut is made 80 that about 2 to 4 mm of t~-F'l~ remains from the edge of the hole to the pseudo-~nn~lA~ line, and about 3 to 5 mm of tis~ue remain~ between the hole edge and the commissures. All trimming i6 conducted with the goal of leaving an intact band of aorta about 2 to 5 mm in width above the two coronary oren;nqs 47. The intact band of aorta is necess~ry to maintain proper alignment of the commissures and prevent distortion of the valves during suturing.
Finally, the inflow rim is trimmed on the ~ame plane as the cusps of the leaflets, usually leaving an intact segment of about 3 to 4 mm in width a~ measured from the hinge of the leaflet. All of the fatty tissue in the aorta i~ trimmed away.
As 6hown in Figure 3, the resulting aortic ~egment contains three valve leaflet~, each of which is affixed to the aortic ~egment at a ~uncture. Aortic valve 13, excised from a porcine heart, includes a tubular aortic 6egment of the ascending aorta 19 and three valve leaflets 21, 23, and ; ll 2~3~5~
_ 25. The bulk of the ~yocardial t~ ? has been trimmed from valve 13 to ~inimize distortion during $ixation, and the coron~ry arteries (not shown) have been cut out as above described. Adjacent ~dge~ of the valve leaflets 21,23, and 25 ~eet to form eommi~sures 27 at the ~unctions between adjacent valve leaflets. Each of the valve leaflet~ 21, 23 and 25 can be con~idered a~ ~oined to ~rcenAing aorta 19 along a ~uncture 29. The wall of the ~cenA;ng aorta 19 adjacent ~ ~u~e 29 form~ ~n"re~ of Valsalva (not ~hown). Valve leaflet 21, the right coronary leaflet, iB positioned ~omewhat asymmetrically with ~ ect to the other two leaflets.
The cloth covering i8 made of any ~mooth, thin biocompatible material D L. ~ly ~no--7h to hold sutures, but is preferably of white dacron, ~uch as that manufactured by Bard Cardiosurgery Division, C. R. Bard, Inc. under part no. 6103, having a thic~ne~s of .008 ~c~es and a weight of 72 grams per ~quare meter. The cloth is cut on the diagonal to assure a snug fit around ~Lved surfaces, cleaned to remove contaminants such as dirt and lint, preferably by submerging in Freon for 60 ~econ~, and sterilized.
As shown in Figure 3, at the inflow end the entire right coronary septal shelf 33 is covered externally by a piece of cloth 32 stitched into place, preferably by hand, using a nondi~solvable biocompatible thread and whipstitches 35 at the thin rim adjacent to the right coronary septal ~helf 37. The inflow rim 39 is covered, preferably starting at the ~u..e~u-e of the left and noncoronary cusps 41, by a piece of cloth 32 folded at the half-width ~o that approximately 2.S mm. of cloth extends on each side of the fold. The rim to be covered is placed within the fold. Therefore, the cloth covering extends SJ1~
~long the inflow rim, both internally and externally, and along the exterior curface of the entire right coronary ~eptal ~helf. Preferably this ~egment of cloth i~ a ~ingle piece.
s ~ arking~ 43, for example, ~titches ~n a ~G..L.~sting color of thread, are located on the cloth curface along the inflow rim, preferably at the ~id-cusp point of each leaflet, to ~id the ~u~eG~ in ~ligning the valve within the patient's natural aorta. For in~tance, if the cloth is white, the marking can be ctitches of navy blue threAd, ~nd the like. An exemplary light green marking thread is Polyester Teflon Coated Polydek, ~ize 6.0, having a denier of 110-130 manufa~L~ed by Dekatel C~o~ation, Queens Village, New York.
As ~hown in Figure 4, at the outflow ~ide, cloth 32 is sewn only on the internal portion of the valve. Surgeons use the coverings on the outflow ~ide of the valve as an anchor and a ~Lule guide, ~o they must be placed far enough from the leaflets to pose no risk of placing a suture through the leaflet and thus damaging or rendering the valve incompetent. Two pieces of cloth are required, cut diagonally by laser to about 2 to 4 mm, preferably about 2.5 to 3.5 mm in width, to run along and match the shape of edge of the coronary artery openings. The length of these pieceC of cloth is determined by the reguirement that about 1 to 4 mm, prefer~bly about 2.5 to 3.0 mm of ~pace, must be left between each end of the cloth and the nearest commi~ure 48.
As ~hown in detail in Figure 4, at outflow rim 46 cloth 32 i~ sewn to cover the area running internally directly along the pseudoannulus 45 of the valve and over the cutouts for both the right and left coronary arteries ~3 47, but the ~L~ e cribed ~-~o~ered np~le is left L~/aen the edges of the cloth and each valve commi6sure.
The cloth covering thu~ giveQ ~u~v~L to an area commonly known in the art a~ the -~con~ .~L~e line and provide~
secure ~un~ for the ~u~eo.. to place the ~econd line.
The cloth piece~ are permanently attached to the aortic ~egment by stitch~g them into place w~th fine ~titches, preferably by hand, u~ing ~ ~n~ olvable biocompatible thread. Preferably one edge of the cloth is cecured by a line of in-and-out ~titches 51 about 0.5 mm in length placed immediately above the ~ s~nnulus line utilizing Teflon thread ~uch as that manufa~L~ed by W. L.
Gore and ~crocjAteC~ Inc., Elkton, MD., having a denier of 200-250, monofilament zero twi t (Part ~ YlD162 PTFE). The other edge of the cloth i8 ~u~led to the hole edge with whipstitches 53 ~n~ng along the inside of the coronary open;n~s using the ~ame piece of Teflon thread, while making sure that the cloth is fluuh with the hole edge.
Although the valve holder body can be of any cize and shape ~uitable to be ~ecured adjacent to the aortic 6egment and made of a biocompatible substance, valve holder body 55 preferably comprises two cylindrical ~egments extruded from a biocompatible plastic ~uch as transparent polysulfone thermoplastic ~old by Union Carbide Co~oL&tion as part P 1700-11, having a tensile yield ~trength of 9,500 psi min. Preferably the holder body is ~ized to fit within the ~en;~g of the aortic ~egment.
As ~hown in Figures 5 and 6, a first cylindrical ~egment 57 of valve holder body 55 has axis 59 and is hollow, having an internal diameter of from about 3.5 mm to 6.5 mm, and an external diameter of from about 5 mm to 10 ~ . ~ ~
14 2~ 51~
- mm, ~ost preferably about 7 Ym, and a length of from about 4 mm to 16 mm, Dost preferably about 6 ~m. Joined thereto and ~oaY~ al ly aligned therewith i6 -eCOnA
eylindrieal ~egment 61 having an external diameter of from S about 8 D to 13 ~m, ~o~t preferably ~bout lO mm, and length of from about 2 D to 8 D, ~ost preferably ~bout 4 mm. A ~oaYially aligned eylindrieal d~ ion 63 extends into eylindrieal ~egment 61 for a depth egual to about one half the length of the ~egment. The diameter of eylindrieal ~ ion C3 i~ egual to the internal diameter of fir~t eylindrieal ~egment 57. Therefore, with fir~t and Aecon~ eylindrieal ~egments ~oined, the interior wall of eylindrieal 6egment 57 and eylindrieal depression 63 define eylindrieal ~pace 65, the ~ides of whieh have threads (not ~hown) for receiving the threaded end 69 of ~n~le 71.
uAn~le 71 i~ a eylindrieal rod ~ized to fit into eylindrieal spaee 65 by means of threads at end 69 ~o that handle 71 ean be ~lewe-l into valve holder body 55. Holes 80 extend through eylindrieal ~egment 61 to provide a means for attaching the holder body to the prosthetie aortic valve.
Any of a number of Deans ean be used for detachably eonnecting the holder body to the heart valve so long as they do not eompromise the integrity of the leaflets. The preferred means for attaching the holder body to an aortic prosthesis i~ ~hown in Figure 7. From one to about six, most preferably four, loose ~uture threads 81 are threaded through holes 80 provided in the holder body as well as eompletely through the wall of the outflow ~ide of the aortie segment 55, preferably through the tissue above the openings for the eoronary arteries 47. The ~uture threads are then fastened (i.e. tied) as shown in Figure 7 ~o that the holder body hangs ~uspended within the 6aid outflow opening. This ~imple Deans of attaehment ean readily be 2 ~ ~ ~ J .~ ~
snipped by the surgeon and the holder body and BULULe~ can be removed once the first suture line h~s been placed, or at ~ny time during the surgical implant ~ re.
As an ~dditional advantage, the band of aortic segment on the outflow ~ide of the valve optionally can be trimmed to fit the needs of the part~ r patient and/or the likings of the surgeon. For instance the outflow ~ide of the valve can be trimmed ~o as to completely remove the portion of the aortic band ~xt~n~ ng between the outflow rim and the coronary artery openings. Trimming the flexible prosthetic valve in this way does not de_L~oy its natural shape or function.
Although exemplary embodiments of the invention have been shown and described, many changes, modifications and substitutions may be made by one having ordinary skill in the art without nec~6s~rily departing from the spirit and scope of the invention described and claimed herein.
Claims (52)
PROPERTY OR PRIVILEGE IS CLAIMED ARE DEFINED AS FOLLOWS:
1. A stentless aortic valve prosthesis comprising an animal aortic segment having an external surface and an internal surface, the aortic segment further comprising an aortic root, an outflow rim adjacent the aortic root, an inflow rim, a left coronary artery, a right coronary artery, a right coronary septal shelf, a plurality of valve leaflets, each valve leaflet having cusps and edges with the adjacent edges of the valve leaflets meeting to form commissures, a pseudoannulus line located adjacent the commissures along the internal surface of the aortic segment, and coronary openings formed by cutting away the left and right coronary arteries while leaving intact a band of aortic wall adjacent the outflow rim.
2. The prosthesis of Claim 1, further comprising a suturable covering affixed along the entire right coronary septal shelf on the external surface of the aortic segment, and the inflow rim on both the internal and external surfaces of the aortic segment.
3. The prosthesis of Claim 2, wherein the suturable covering further comprises edges, and further covers, at the outflow rim, an area running along the internal surface of the aortic segment between the pseudoannulus line and the coronary openings, leaving uncovered a portion of aortic wall between the edges of the suturable covering and each commissure.
4. The prosthesis of Claim 2 wherein the prosthesis is manually reversible and wherein the suturable covering is a biocompatible cloth stitched flat to the aortic segment with nondissolvable biocompatible thread.
5. The prosthesis of Claim 4 wherein the thread is Teflon.R
6. The prosthesis of Claim 4 wherein the cloth is cut on the diagonal.
7. The prosthesis of Claim 4 wherein the cloth is laser cut.
8. The prosthesis of Claim 4 wherein the cloth covering the pseudoannulus line and the coronary openings comprises two pieces from 2 to 4 millimeters in width diagonally cut to match the shape of the left and right coronary arteries wherein from 1 to 4 millimeters of space is left uncovered between each send of the cloth and the nearest commissure.
9. The prosthesis of Claim 8 wherein the cloth has an edge and the coronary openings further comprise edges, and wherein the stitches comprises a line of in-and-out stitches about 0.5 millimeter in length placed between the pseudoannulus line and the coronary openings, and a line of whipstitches running along the edge of the cloth adjacent to the edges of the coronary openings.
10. The prosthesis of Claim 4 wherein each valve leaflet comprises a mid-cusp point, and wherein the cloth covering the inflow rim extends from about 2 to 3 millimeters one each side of the rim and wherein markings are located on the cloth surface along the inflow rim about each of the mid-cusp points.
11. The prosthesis of Claim 10 wherein the cloth is white Dacron and the markings are stitches in a contrasting color of thread.
12. The prosthesis of Claim 1 wherein the coronary openings comprise edges and wherein the band of aortic wall remains intact for a distance of from 2 to 4 millimeters from the outflow rim to the edge of the coronary openings.
13. The prosthesis of Claim 12 wherein the intact band of aortic wall has a width of 2 to 5 millimeters.
14. The prosthesis of Claim 1 further comprising a distance from the edge of the coronary openings to the commissures, and wherein the distance is from about 2 to 5 millimeters.
15. The prosthesis of Claim 1 further comprising a thin rim of cartilage adjacent to the right coronary shelf.
16. The prosthesis of Claim 1 wherein the inflow rim is trimmed on the same plate as the cusps of the valve leaflets.
17. The prosthesis of Claim 16 wherein the plurality of valve leaflets comprise hinges, and wherein the inflow rim has a segment of intact aortic wall between 3 and 4 millimeters in width as measured from the hinges of the valve leaflets.
18. A stentless aortic valve prosthesis comprising an animal aortic segment having an external surface and an internal surface, the aortic segment further comprising an aortic root, an outflow rim adjacent the aortic root, an inflow rim, a left coronary artery, a right coronary artery, a right coronary septal shelf, a plurality of valve leaflets, each valve leaflet having cusps and edges with the adjacent edges of the valve leaflets meeting to form commissures, and a pseudoannulus line located adjacent the commissures along the internal surface of the aortic segment, the aortic segment further comprising:
coronary openings formed by cutting away the left and right coronary arteries while leaving intact a band of aortic wall adjacent the outflow rim; and a suturable covering affixed along the entire right coronary septal shelf on the external surface of the aortic segment, and the inflow rim on both the internal and external surfaces of the aortic segment; the suturable covering comprising edges and covering, at the outflow rim, an area running along the internal surface of the aortic segment between the pseudoannulus line and the coronary openings, leaving uncovered a portion of aortic wall between the edges of the suturable covering and each commissure.
coronary openings formed by cutting away the left and right coronary arteries while leaving intact a band of aortic wall adjacent the outflow rim; and a suturable covering affixed along the entire right coronary septal shelf on the external surface of the aortic segment, and the inflow rim on both the internal and external surfaces of the aortic segment; the suturable covering comprising edges and covering, at the outflow rim, an area running along the internal surface of the aortic segment between the pseudoannulus line and the coronary openings, leaving uncovered a portion of aortic wall between the edges of the suturable covering and each commissure.
19. The prosthesis of Claim 18 wherein the coronary openings comprise edges and wherein the band of aortic wall remains intact for a distance of from 2 to 4 millimeters from the outflow rim to the edge of the coronary openings.
20. The prosthesis of Claim 18 further comprising a distance from the edge of the coronary openings to the commissures, and wherein the distance is from about 2 to 5 millimeters.
21. A combination valve holder and prosthetic aortic segment comprising:
a stentless aortic valve prosthesis comprising an animal aortic segment having an external surface and an internal surface, the aortic segment further comprising an aortic root, an outflow rim adjacent the aortic root, an inflow rim, a left coronary artery, a right coronary artery, a right coronary septal shelf, a plurality of valve leaflets, each valve leaflet having cusps and edges with the adjacent edges of the valve leaflets meeting to form commissures, a pseudoannulus line located adjacent the commissures along the internal surface of the aortic segment, and coronary openings formed by cutting away the left and right coronary arteries while leaving intact a band of aortic wall adjacent the outflow rim;
a disposable holder body having an elongate detachable handle; and a plurality of means for detachably attaching the holder body to the covering on the aortic segment.
a stentless aortic valve prosthesis comprising an animal aortic segment having an external surface and an internal surface, the aortic segment further comprising an aortic root, an outflow rim adjacent the aortic root, an inflow rim, a left coronary artery, a right coronary artery, a right coronary septal shelf, a plurality of valve leaflets, each valve leaflet having cusps and edges with the adjacent edges of the valve leaflets meeting to form commissures, a pseudoannulus line located adjacent the commissures along the internal surface of the aortic segment, and coronary openings formed by cutting away the left and right coronary arteries while leaving intact a band of aortic wall adjacent the outflow rim;
a disposable holder body having an elongate detachable handle; and a plurality of means for detachably attaching the holder body to the covering on the aortic segment.
22. The combination of Claim 21 wherein the means for attaching comprise holes drilled through the holder body.
23. The combination of Claim 22 wherein the means for attaching is selected from the group consisting of sutures, wires and elastic materials.
24. The combination of Claim 22 wherein the means for attaching further comprise suture threads passing through the holes and through the orifice of the valve whereby the holder body is suspended within the orifice of the valve.
25. The combination of Claim 21 wherein the holder body comprises a biocompatible plastic.
26. The combination of Claim 25 wherein the plastic comprises polysulfone.
27. The combination of Claim 21 wherein the handle comprises a metal rod.
28. The combination of Claim 27 wherein the handle is threaded and screws into a threaded cylindrical depression in the holder body.
29. The combination of Claim 21 wherein the holder body comprises a first right cylindrical section conjoined to and coaxially aligned with a second right cylindrical section of greater diameter and wherein a coaxially aligned right cylindrical depression runs throughout the first cylindrical section and penetrates into the second cylindrical section, the walls of the cylindrical section having threads thereon and further wherein the handle is a rod having threads along one end so that the handle can be detachably affixed to the holder body by screwing the threaded end of the handle into the cylindrical depression.
30. The combination of Claim 29 wherein the handle comprises metal.
31. The combination of Claim 29 wherein the handle comprises a biocompatible plastic.
32. The combination of Claim 29 wherein the first right cylindrical section has a diameter from about 5 to 10 millimeters and has a length of from about 4 to 16 millimeters and wherein the second right cylindrical section has a diameter from about 8 to 13 millimeters and a length of from about 2 to 8 millimeters and wherein the length of the sides of the cylindrical depression is from about 4 to 22 millimeters.
33. The combination of Claim 32 wherein a plurality of spaced bore holes in the range from one to six extend through the second cylindrical section in the portion of the second cylindrical section extending beyond the jointure with the first cylindrical section and further wherein the attachment means are suture threads passed through the aortic segment and the bore holes and secured so as to suspend the holder body within the outflow orifice of the aortic segment.
34. The combination of Claim 21 wherein said prosthesis comprises:
a low-pressure tanned animal aortic segment having intact the aortic valve and retaining the natural shape and flexibility;
wherein said band of aortic wall is at least about 2 millimeters wide; and a suturable covering affixed along the entire right coronary septal shelf externally, and the inflow rim both internally and externally, and covering at the outflow rim the area running internally directly above the pseudoannulus line and along the coronary openings, leaving uncovered a portion of aortic wall from 2 to 3.5 millimeters in width between the edges of the covering and each valve commissure.
a low-pressure tanned animal aortic segment having intact the aortic valve and retaining the natural shape and flexibility;
wherein said band of aortic wall is at least about 2 millimeters wide; and a suturable covering affixed along the entire right coronary septal shelf externally, and the inflow rim both internally and externally, and covering at the outflow rim the area running internally directly above the pseudoannulus line and along the coronary openings, leaving uncovered a portion of aortic wall from 2 to 3.5 millimeters in width between the edges of the covering and each valve commissure.
35. The combination of claim 21 wherein said prosthesis comprises:
a low pressure tanned porcine aortic segment having intact the aortic valve and retaining the natural shape and flexibility;
wherein said band of aortic wall is at least about 2 millimeters wide;
cloth covering the entire right coronary septal shelf externally, and the inflow rim both internally and externally, and covering at the outflow rim the area running internally directly above the pseudoannulus line and along the coronary openings, leaving uncovered a portion of aortic wall from 2 to 3.5 millimeters in width between the edges of the cloth and each valve commissure;
wherein the cloth is stitched flat to the aortic segment along each edge with nondissolvable biocompatible thread and wherein a circular band of aortic wall remains intact for a distance of from 2 to 4 millimeters from the pseudo-annular line to the edge of the coronary openings;
and further wherein said band of aortic wall can be trimmed to remove the portions contiguous to the coronary artery openings without impairing the shape or the function of the valve.
a low pressure tanned porcine aortic segment having intact the aortic valve and retaining the natural shape and flexibility;
wherein said band of aortic wall is at least about 2 millimeters wide;
cloth covering the entire right coronary septal shelf externally, and the inflow rim both internally and externally, and covering at the outflow rim the area running internally directly above the pseudoannulus line and along the coronary openings, leaving uncovered a portion of aortic wall from 2 to 3.5 millimeters in width between the edges of the cloth and each valve commissure;
wherein the cloth is stitched flat to the aortic segment along each edge with nondissolvable biocompatible thread and wherein a circular band of aortic wall remains intact for a distance of from 2 to 4 millimeters from the pseudo-annular line to the edge of the coronary openings;
and further wherein said band of aortic wall can be trimmed to remove the portions contiguous to the coronary artery openings without impairing the shape or the function of the valve.
36. The combination of Claim 21 wherein said prosthesis comprises:
a reversible porcine aortic segment having intact the aortic valve and retaining the natural shape and flexibility;
wherein said band of aortic wall is at least about 2 millimeters wide;
cloth covering the entire right coronary septal shelf externally, and the inflow rim both internally and externally, and covering at the outflow rim the area running internally directly above the pseudoannulus line and along the coronary openings, leaving uncovered a portion of aortic wall from 2 to 3.5 millimeters in width between the edges of the cloth and each valve commissure;
wherein the cloth is stitched flat to the aortic segment along each edge with nondissolvable biocompatible thread, wherein the aortic wall remains intact for a distance of from 2 to 4 millimeters from the pseudo-annular line to the edge of the coronary openings, and wherein the distance from the edge of the coronary openings to the commissures is from about 2 to 5 millimeters.
a reversible porcine aortic segment having intact the aortic valve and retaining the natural shape and flexibility;
wherein said band of aortic wall is at least about 2 millimeters wide;
cloth covering the entire right coronary septal shelf externally, and the inflow rim both internally and externally, and covering at the outflow rim the area running internally directly above the pseudoannulus line and along the coronary openings, leaving uncovered a portion of aortic wall from 2 to 3.5 millimeters in width between the edges of the cloth and each valve commissure;
wherein the cloth is stitched flat to the aortic segment along each edge with nondissolvable biocompatible thread, wherein the aortic wall remains intact for a distance of from 2 to 4 millimeters from the pseudo-annular line to the edge of the coronary openings, and wherein the distance from the edge of the coronary openings to the commissures is from about 2 to 5 millimeters.
37. The combination of Claim 21, further comprising a suturable covering affixed along the entire right coronary septal shelf on the external surface of the aortic segment, and the inflow rim on both the internal and external surfaces of the aortic segment.
38. The combination of Claim 37 wherein the suturable covering further comprises edges, and further covers, at the outflow rim, an area running along the internal surface of the aortic segment between the pseudoannulus line and the coronary openings, leaving uncovered a portion of aortic wall between the edges of the suturable covering and each commissure.
39. The combination of Claim 37, wherein the prosthesis is manually reversible and wherein the suturable covering is a biocompatible cloth stitched flat to the aortic segment with nondissolvable biocompatible thread.
40. The combination of Claim 39 wherein the thread is Teflon.R
41. The combination of Claim 39 wherein the cloth is cut on the diagonal.
42. The combination of Claim 39 wherein the cloth is laser cut.
43. The combination of Claim 39 wherein the cloth covering the pseudoannulus line and the coronary openings comprises two pieces from 2 to 4 millimeters in width diagonally cut to match the shape of the left and right coronary arteries wherein from 1 to 4 millimeters of space is left uncovered between each send of the cloth and the nearest commissure.
44. The combination of Claim 43 wherein the cloth has an edge and the coronary openings further comprise edges, and wherein the stitches comprises a line of in-and-out stitches about 0.5 millimeter in length placed between the pseudoannulus line and the coronary openings, and a line of whipstitches running along the edge of the cloth adjacent to the edges of the coronary openings.
45. The combination of Claim 39 wherein each valve leaflet comprises a mid-cusp point, and wherein the cloth covering the inflow rim extends from about 2 to 3 millimeters one each side of the rim and wherein markings are located on the cloth surface along the inflow rim about each of the mid-cusp points.
46. The combination of Claim 45 wherein the cloth is white Dacron and the markings are stitches in a contrasting color of thread.
47. The combination of Claim 21 wherein the coronary openings comprise edges and wherein the band of aortic wall remains intact for a distance of from 2 to 4 millimeters from the outflow rim to the edge of the coronary openings.
48. The combination of Claim 47 wherein the intact band of aortic wall has a width of 2 to 5 millimeters.
49. The combination of Claim 21 further comprising a distance from the edge of the coronary openings to the commissures, and wherein the distance is from about 2 to 5 millimeters.
50. The combination of Claim 21 further comprising a thin rim of cartilage adjacent to the right coronary shelf.
51. The combination of Claim 21 wherein the inflow rim is trimmed on the same plate as the cusps of the valve leaflets.
52. The combination of Claim 51 wherein the plurality of valve leaflets comprise hinges, and wherein the inflow rim has a segment of intact aortic wall between 3 and 4 millimeters in width as measured from the hinges of the valve leaflets.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US07/579,464 US5197979A (en) | 1990-09-07 | 1990-09-07 | Stentless heart valve and holder |
| US579,464 | 1990-09-07 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CA2086515A1 CA2086515A1 (en) | 1992-03-08 |
| CA2086515C true CA2086515C (en) | 1997-12-02 |
Family
ID=24317014
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002086515A Expired - Lifetime CA2086515C (en) | 1990-09-07 | 1991-08-29 | Stentless heart valve and holder |
Country Status (7)
| Country | Link |
|---|---|
| US (2) | US5197979A (en) |
| EP (1) | EP0547135B1 (en) |
| JP (1) | JP3282728B2 (en) |
| AU (1) | AU651620B2 (en) |
| CA (1) | CA2086515C (en) |
| DE (1) | DE69132893T2 (en) |
| WO (1) | WO1992003990A1 (en) |
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-
1990
- 1990-09-07 US US07/579,464 patent/US5197979A/en not_active Expired - Lifetime
-
1991
- 1991-08-29 DE DE69132893T patent/DE69132893T2/en not_active Expired - Lifetime
- 1991-08-29 WO PCT/US1991/006255 patent/WO1992003990A1/en active IP Right Grant
- 1991-08-29 EP EP91916465A patent/EP0547135B1/en not_active Expired - Lifetime
- 1991-08-29 CA CA002086515A patent/CA2086515C/en not_active Expired - Lifetime
- 1991-08-29 AU AU85074/91A patent/AU651620B2/en not_active Expired
- 1991-08-29 JP JP51515091A patent/JP3282728B2/en not_active Expired - Lifetime
-
1992
- 1992-12-14 US US07/990,211 patent/US5336258A/en not_active Expired - Lifetime
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|---|---|
| AU651620B2 (en) | 1994-07-28 |
| AU8507491A (en) | 1992-03-30 |
| EP0547135B1 (en) | 2002-01-09 |
| EP0547135A1 (en) | 1993-06-23 |
| CA2086515A1 (en) | 1992-03-08 |
| JP3282728B2 (en) | 2002-05-20 |
| DE69132893T2 (en) | 2002-09-12 |
| DE69132893D1 (en) | 2002-02-14 |
| JPH06500719A (en) | 1994-01-27 |
| US5197979A (en) | 1993-03-30 |
| US5336258A (en) | 1994-08-09 |
| WO1992003990A1 (en) | 1992-03-19 |
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